The Biden administration’s fiscal year 2024 budget proposal, announced yesterday, aims to eliminate hepatitis C from the United States by creating a national program to combat the disease. If funded by Congress, the $11.3 billion, five-year program would expand testing, expand access to powerful antiviral drugs and increase awareness.
“I can’t really remember an occasion like this where we have an opportunity to do something so groundbreaking, so we just have to figure out how to make it work,” Frances Collins, acting science adviser to President Joe Biden and former chief of National Institute of Health (NIH), said in an interview in GLASSwhich also published an editorial co-authored by Collins supporting the proposed program.
“The field has been waiting for this for a long time,” says transplant hepatologist David Kaplan of the University of Pennsylvania Perelman School of Medicine. Eliminating the disease “is possible and achievable,” he says, noting that other countries are on track to achieve that goal. But that doesn’t mean the effort will be easy, adds pediatric hepatologist James Squires of UPMC Children’s Hospital of Pittsburgh. “It will be a challenge. There has never been an eradication of an infectious virus without a vaccine.”
Hepatitis C kills more than 15,000 people in the United States each year. The virus that causes it is spread mainly through intravenous drug use and attacks the liver, often eventually causing cirrhosis, liver failure and cancer. Although statistics are shaky because of limited testing, the Centers for Disease Control and Prevention estimates that 2.4 million people in the United States have the hepatitis C virus. Pediatric hepatologist William Balistreri of the University of Cincinnati says the number could be as high as the 10 million.
Despite the lack of a vaccine, researchers can talk seriously about eradicating hepatitis C because drugs known as direct-acting antivirals (DAAs), first approved in the United States in 2013, are so effective. These drugs, such as the combination of sofosbuvir and ledipasvir sold as Harvoni, can clear the virus from more than 95% of patients with just 8 to 12 weeks of treatment. The introduction of DAAs prompted the World Health Organization (WHO) to make the elimination of hepatitis C by 2030 one of its goals. The disease would not disappear like smallpox, which was defeated with a powerful vaccine. Instead, the WHO aims to reduce new cases by 90% and deaths by 65%.
A survey published earlier this year revealed that 11 countries were on track to meet WHO targets. One is Egypt, which reduced its alarmingly high rate of infection by testing more than 50 million residents and treating 4 million who tested positive. Other countries, including Australia, Japan, Georgia and many countries in Europe, have made similar progress. The United States has lagged because it lacks a national effort and because formidable barriers prevent many of the infected people from being diagnosed and treated. “We can treat these patients,” says Kaplan. “But there are too many steps to get them treated.”
For example, estimates show that about 10% of the approximately 2 million people in the United States who are in jail or prison carry the virus, but often go without testing and treatment. For this group, “We need more resources for testing and a cultural change in the availability of treatment,” says Matthew Akiyama, a clinician-researcher at the Albert Einstein College of Medicine.
The new plan proposed by the Biden administration outlines several steps to reduce such barriers. In other countries, for example, patients can undergo so-called point-of-care RNA testing at locations such as community health centers and substance abuse treatment clinics. If they are positive, they can be treated at the same visit. But in the United States, the tests must be processed at off-site labs, forcing patients to return to get the results and further delaying their treatment. The program would accelerate the approval of point-of-care RNA tests by joining the Independent Test Evaluation Program, an NIH-Food and Drug Administration collaboration.
The initiative will also tackle one of the biggest barriers to treatment – the cost of drugs. Although the price of DAAs has dropped by about 75% since they were introduced, a full course still costs about $20,000. To improve treatment for incarcerated and other underserved populations, the program will adopt a so-called subscription model, or Netflix, first tried by Louisiana, in which the government pays drug companies a set amount for as much medicine as needed. from payment by installments.
The amount of money budgeted for the program may not be enough to eliminate hepatitis C, Kaplan says, but “it will make a significant dent in the problem.” The administration has proposed funding the full 5-year program as a mandatory expense, meaning no money would need to be set aside each year. But the effort needs approval from Congress, including the Republican-controlled House of Representatives, which intends to cut federal spending.
Failure to take advantage of this opportunity would be a huge loss, says Balistreri. “We can do it. Shame on us if we don’t.”